A Double-Blind Crossover Evaluation of Ketoprofen (Orudis®) and Placebo in Rheumatoid Arthritis with Assessment of Long-Term Tolerance

1978 ◽  
Vol 6 (4) ◽  
pp. 300-305 ◽  
Author(s):  
D L G Howard
Keyword(s):  
Rheumatoid Arthritis ◽  
Active Rheumatoid Arthritis ◽  
Good Control ◽  
Double Blind Study ◽  
Double Blind ◽  
Single Instance ◽  
Efficacy Estimate ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

A two-week double-blind crossover study of ketoprofen, a non-steroidal antiinflammatory agent, and placebo was done in ten patients with active rheumatoid arthritis in order to obtain a preliminary efficacy estimate of this new drug. Even after only one week of treatment, joint activity was significantly reduced while other parameters of disease activity showed strong clinical trends in favour of the drug. Only one adverse reaction (mild nausea) was reported during ketoprofen therapy. At the conclusion of the double-blind study, seven patients volunteered to continue on ketoprofen to evaluate the tolerance of the drug during protracted administration. All patients completed over twelve months of treatment. Overall, ketoprofen gave good control of pain and inflammation, gastro-intestinal disturbance was reported in a single instance and laboratory values were not adversely affected by the drug.

A Double-Blind Study of SB-220453 (Tonerbasat) in the Glyceryltrinitrate (GTN) Model of Migraine

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 875-882 ◽  
Author(s):  
JF Tvedskov ◽  
HK Iversen ◽  
J Olesen
Keyword(s):  
Animal Models ◽  
International Headache Society ◽  
Human Model ◽  
Double Blind Study ◽  
Double Blind ◽  
Nerve Ganglion ◽  
Hypotensive Episode ◽  
Ihs Criteria ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

The need for experimental migraine models increases as therapeutic options widen. In the present study, we investigated SB-220453 for efficacy in the glyceryltrinitrate (GTN) human experimental migraine model. SB-220453 is a novel benzopyran compound, which in animal models inhibits neurogenic inflammation, blocks propagation of spreading depression and inhibits trigeminal nerve ganglion stimulation-induced carotid vasodilatation. We included 15 patients with migraine without aura in a randomized double-blind crossover study. SB-220453 40 mg or placebo was followed by a 20-min GTN infusion. Headache, scored 0-10, was registered for 12 h, and fulfillment of International Headache Society (IHS) criteria was recorded until 24 h. Four subjects had a hypotensive episode after SB-220453 plus GTN but none after GTN alone. The reaction was unexpected, since animal models and previous human studies had shown no vascular or sympaticolytic activity with SB-220453. The study was terminated prematurely due to this interaction. GTN was consistent in producing headache and migraine that resembled the patients' usual spontaneous migraine. Nine patients had GTN on both study days. Peak headache score showed a trend towards reduction after SB-220453 compared with placebo (median 4 vs. 7, P = 0.15). However, no reduction was seen in the number of subjects experiencing delayed headache (8 vs. 8), number of subjects reporting migraine (6 vs. 8), migraine attacks fulfilling IHS criteria 1.1 or 1.7 (6 vs. 7) or IHS 1.1 alone (4 vs. 5). SB-220453 had no significant pre-emptive anti-migraine activity compared with placebo in this human model of migraine. Interaction between SB-220453 and GTN was discovered. This is important for the future development of the compound and underlines the usefulness of experimental migraine models.

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